Risk management recommendations on the revocation of an authorisation for one regulated feed product
Published 10 July 2026
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This publication is available at https://www.gov.uk/government/consultations/proposed-revocation-of-one-regulated-feed-product-2026/risk-management-recommendations-on-the-revocation-of-an-authorisation-for-one-regulated-feed-product
1. Date of publication: 10 July 2026
1.1 Document subject and purpose
In this document we publish the Food Standards Agency (FSA) risk management recommendations on the proposed revocation of an authorisation for one feed additive.
Our risk assessors deliver the science behind our advice and publish their safety assessment. Risk assessors are responsible for identifying and characterising hazards and risks to health and assessing levels of exposure.
The risk management recommendations consider the safety assessment (which represents the opinion of the FSA for this additive) as well as potential impacts that may result from the revocation of the authorisation of this additive. They also consider other legitimate factors that ministers may want to consider before making a decision on the proposed revocation of the authorisation of this additive.
The final FSA recommendations that are made to ministers in England and Wales will consider stakeholders’ views received from this consultation.
2. FSA Risk Management Recommendations: Patent Blue V (2a131) (Revocation) (Feed additive)
A lack of evidence provided means the FSA cannot conclude on the safety of the feed additive Patent Blue V. It is for ministers in England and Wales to decide whether to revoke the authorisation of use of this feed additive.
2.1 Introduction
An application was submitted by Versele-Laga NV in July 2022 for the renewal of authorisation of Patent Blue V, an animal feed additive under the category ‘Sensory additives’, and the functional group ‘colourants - substances that add or restore colour in feedingstuffs’, for use in non-food producing animals.
As a result of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (‘the Food and Feed Regulations 2025’), feed additive authorisations that, prior to 1 April 2025, were subject to renewal requirements, no longer have a fixed expiry date and there is no longer a requirement for renewal applications.
However, whilst the Food and Feed Regulations 2025 removed the requirement for feed additive authorisation renewal applications, the FSA and Food Standards Scotland (FSS) undertook a review of the safety of this additive due to a potential safety concern regarding aneugenicity.
2.2 Safety Assessment Summary
The FSA and FSS determined that it was necessary to issue a safety assessment in connection with the authorisation for Patent Blue V (2a131) for use in non-food-producing animals under Article 12(A) and 13 of assimilated Regulation (EC) No 1831/2003.
The views of the Advisory Committee on Animal Feedingstuffs (ACAF) were considered in preparing the safety assessment.
Key conclusions from the safety assessment included the following:
- Due to insufficient information, the additive was not fully characterised.
- The ACAF could not discard the aneugenicity potential of the additive, and could therefore not conclude on the safety for the target species of Patent Blue V.
- The FSA accepts the European Union Reference Laboratory (EURL) analytical method evaluation reports previously verified for the authorisation of this feed additive made under assimilate Regulation(EU) 643/2013. The FSA determined the analytical methods proposed as appropriate for official controls for this Feed additive. The analytical methods were approved in 2012, at the time in which the UK was still an EU member.
It is proposed that the authorisation of the Feed additive ‘Patent Blue V’ should be revoked in accordance with Article 13 of assimilated Regulation (EU) No 1831/2003 with the implementation of appropriate transitional provisions. This refers to the authorisation of ‘Patent Blue V’ in England and Wales as a feed additive under the category ‘Sensory additives’ and the functional group ‘colourants- substances that add or restore colour in feedingstuffs’, for its use in non-food producing animals under the terms as set out on the GB Feed Additives Register.
2.3 Any Relevant Provisions of assimilated law
Legislation in respect of Feed additives applies to this application. In particular, it is noted that a number of provisions of [assimilate Regulation(EC) 1831/2003] (https://www.legislation.gov.uk/eur/2003/1831/contents) are relevant:
- Article 5: Conditions for authorisation
- Article 6 and Annex I: Categories of feed additives and functional groups
- Article 12A: Supervision
- Article 13: Issuing of safety assessment and determination of modifications, suspensions and revocations
- Article 16 and Annex III: Labelling and packaging requirements apply to product permitted on the market
- Article 18: Confidentiality
- Article 21: Analytical methods verified by the European Reference Laboratory (EURL) as used for the control of Patent Blue V in animal feed as detailed in the EURL analytical method evaluation report FAD-2010-0344
- Annex IV: General conditions of use
2.4 Supplementary information
The safety assessment identified the additive’s potential hazard as a:
- Potential skin and eye irritant
- Potential respirator sensitiser
As such, for products remaining on the market during any transitional provisions, particular consideration should be given to these potential hazards arising from the use of this feed additive.
2.5 Labelling
As this is a recommendation for the revocation of this authorisation, we propose that no new labelling is required concerning this feed additive.
2.6 Transitional requirements/ provisions
Under Article 13(6) of assimilated Regulation (EU) No 1831/2003, a revocation of an authorisation may specify a period of time within which existing stocks may be placed onto the market or used.
Our proposal is for a 3-month transitional period within which existing stocks of the additive and premixtures containing the additive, which are intended for non-food producing animals, can be used before being withdrawn from the market
Our proposal is also for a 6-month transitional period within which feed materials and compound feed which have been produced with the additive or premixtures containing it, and which are intended for non-food producing animals, can be used before being withdrawn from the market
These transitional periods are proposed to run from the date that the authorisation is revoked in England and Wales. The products may continue to be lawfully produced in other UK nations.
These transitional arrangements would align with the EU approach.
2.7 Further Explanation/ Rationale
N/A
2.8 Post Market Monitoring
The FSA consider that as this proposal is for the revocation of authorisation of an animal feed additive, and not the authorisation or modification of an authorisation, there is no necessity or requirement to consider imposing post market monitoring. However, for a product placed on the market during transitional arrangements, this product must meet requirements established in assimilated Regulation (EC) No 183/2005 for feed hygiene and good manufacturing practices.
2.9 Definitions
‘Pets and other non-food producing animals’ are defined in Article 1 of assimilated Regulation 429/2008 as “animals belonging to species normally nourished, bred or kept, but not consumed by humans, except horses;”.
2.10 Other Legitimate Factors
None
2.11 Impacts
As part of the risk analysis process, the FSA has assessed the potential impacts that would result from the revocation of the authorisation this feed additive, should ministers agree to revoke. There may be some impact on industry depending on their reliance on this additive. However, as this additive is no longer authorised in the EU and there are authorised alternatives, we expect it is unlikely that there is high industry reliance on this additive.
2.12 Trade
EU
Patent Blue V has not been approved for renewal in the EU. If this feed additive is revoked in England and Wales, then this will align with the EU.
In the EU, transitional arrangements were put in place for 3 months, during which existing stocks of the additive, intended for non-food producing animals, and of premixtures containing it, are to be withdrawn from the market by 1 April 2026.
Transitional arrangements were also put in place for 6 months, during which feed materials and compound feed that have been produced with the additive or premixtures, and are intended for non-food producing animals, are to be withdrawn from the market by 1 July 2026.
The UK Government is negotiating a Sanitary and Phytosanitary (SPS) Agreement with the European Union (EU) following the commitment made at the UK-EU Summit in May 2025. This Agreement would create a common UK-EU SPS Zone and follow a model of dynamic alignment with EU law in SPS policy areas. This includes the law on regulated food and feed products in Great Britain (GB).
The FSA is working across Government to carefully consider and understand the public health implications of an SPS Agreement with the EU. Any future arrangement of this type must protect consumers’ interests in relation to food safety and standards in the UK. The FSA is committed to maintaining our mission to ensure that food is safe and what it says it is as part of an SPS Agreement.
Northern Ireland
Feed additives which are proposed to be placed on the Northern Ireland market are assessed by EFSA. If there is any difference in approach, this is managed through the relevant provisional Common Frameworks. If England and Wales were to revoke this authorisation this would align with the approach taken in the EU (and Northern Ireland).
2.13 Wider Trade Considerations
A WTO notification would be expected under the SPS Agreement, as England and Wales are independently removing an additive from their respective markets. While the measure has trade‑restrictive effects in that it removes a product from circulation, it is justified on public health grounds, based on the underlying safety assessment, and is therefore permissible under WTO rules. Similar EU measures were notified to the WTO and attracted no comments.
2.14 Risk Management Recommendations
The FSA and FSS safety assessment for Patent Blue V was not able to conclude that the feed additive is safe and does not have an adverse effect on the target population, at the intended concentrations of use. Therefore, the FSA recommend that the existing authorisation should be revoked.
Transitional provisions should be implemented to allow time for existing stocks of this feed additive to be withdrawn from the market.
Our recommendation is for a 3-month transitional period within which existing stocks of the additive and premixtures containing the additive, which are intended for non-food producing animals, can be used before being withdrawn from the market.
Our recommendation is also for a 6-month transitional period within which feed materials and compound feed which have been produced with the additive or premixtures containing it, and which are intended for non-food producing animals, can be used before being withdrawn from the market.
These transitional periods are proposed to run from the date that the authorisation is revoked in England and Wales. The products may continue to be lawfully produced in other UK nations.